PDA Letter Article

Alternative to LAL Gains Ground

by Stephenie Overman

Micro exhibition

An alternative to using horseshoe crab blood to test for endotoxins has languished on the U.S. market for almost 15 years. Now, that synthetic alternative may finally be making headway.

Lonza announced last fall that the recombinant Factor C (rFC) assay has been used for endotoxin testing of Eli Lilly and Company’s Emgality migraine prevention treatment. This is the first drug approved by the U.S. FDA using this method instead of traditional limulus amebocyte lysate (LAL)-based methods.